MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-32B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening and malposition involving a tritanium shell was reported.The medical review confirmed loosening and malposition of the shell and also identified inappropriate use of a trident liner.Method & results: device evaluation and results: visual inspection.The reported device was not returned; however, photographs were provided for review.A review of the photos by a clinician states: the poly liner has substantial explantation damage.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: [.] on the acetabular side, the best approach for cementless cups is a higher inclination of the cup shell around 55° to secure optimal fixation around the acetabular bone periphery and then use a 10° offset bearing to reduce effective inclination of the entire cup construct towards more anatomic value around 45°, also anteversion can be improved by positioning the max offset location to postero-superior.For really extreme cases, there even is a 20° offset bearing available.This specific use of offset bearings in cdh is actually the single best application for these types of devices.Some surgeons may prefer cemented cups in cdh and then increase of acetabular coverage is possible by using x-mesh and impaction bone grafting of the superior-lateral acetabulum.[.] device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the investigation concluded that the event was caused by acetabular component malposition with regard to a congenital hip dysplasia deformity and that there was a suboptimal component choice for the type of cdh problem.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "preoperative diagnosis: right failed total hip arthroplasty, complication of prosthetic hip implant¿[surgeon] commented no bony ingrowth to cup, only fibrous¿" a shell, screw, insert, and head were revised.On 27-feb-2019: medical review was received which identified bony impingement between acetabulum and femoral stem, acetabular component malposition and inappropriate selection regarding the trident liner.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8457162
• Report Number: 0002249697-2019-01450
• Device Sequence Number: 19597468
• Product Code: LPH
• UDI-Device Identifier: 07613327025293
• UDI-Public: 07613327025293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 623-00-32B
• Device Lot Number: MKD6Y5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 58